Clinical Trials Register

Summary
EudraCT Number:	2013-001716-30
Sponsor's Protocol Code Number:	CRC-ACNE-AC-04
National Competent Authority:	Germany - BfArM
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2013-08-13
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Germany - BfArM

A.2

EudraCT number

2013-001716-30

A.3

Full title of the trial

Exploratory, controlled, randomized, observer-blind intrainidividual clinical trial to evaluate the efficacy and the tolerability of topically applied 0.1% tyrothricin (Tyrosur® Gel) in patients with mild to severe facial papulopustular acne

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Clinical trial to evaluate the efficacy and the tolerability of topically applied 0.1% tyrothricin (Tyrosur® Gel) in patients with facial acne

A.4.1

Sponsor's protocol code number

CRC-ACNE-AC-04

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Clinical Research Center for Hair and Skin Science
B.1.3.4	Country	Germany
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Charité-Universitätsmedizin Berlin
B.4.2	Country	Germany
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Charité-Universitätsmedizin Berlin, Department of
B.5.2	Functional name of contact point	Dr. Sabine Fimmel
B.5.3	Address:
B.5.3.1	Street Address	Charitéplatz 1
B.5.3.2	Town/ city	Berlin
B.5.3.3	Post code	10117
B.5.3.4	Country	Germany
B.5.4	Telephone number	004930450518122
B.5.5	Fax number	004930450518952
B.5.6	E-mail	sabine.fimmel@charite.de

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Tyrosur® Gel
D.2.1.1.2	Name of the Marketing Authorisation holder	Engelhard Arzneimittel GmbH & Co. KG
D.2.1.2	Country which granted the Marketing Authorisation	Germany
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Tyrosur® 0,1% Gel
D.3.4	Pharmaceutical form	Gel
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Tyrothricin
D.3.9.1	CAS number	1404-88-2
D.3.9.3	Other descriptive name	TYROTHRICIN
D.3.9.4	EV Substance Code	SUB05029MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/g milligram(s)/gram
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	1
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Aknefug® Oxid mild 5%
D.2.1.1.2	Name of the Marketing Authorisation holder	Dr. August Wolff GmbH & Co. KG Arzneimittel
D.2.1.2	Country which granted the Marketing Authorisation	Germany
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Aknefug® Oxid mild 5%
D.3.4	Pharmaceutical form	Gel
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	benzoyl peroxide
D.3.9.3	Other descriptive name	BENZOYL PEROXIDE
D.3.9.4	EV Substance Code	SUB13020MIG
D.3.10	Strength
D.3.10.1	Concentration unit	% (W/W) percent weight/weight
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	5
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 3
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Duac Acne Gel®
D.2.1.1.2	Name of the Marketing Authorisation holder	GlaxoSmithKline/ Stiefel GmbH & Co. KG
D.2.1.2	Country which granted the Marketing Authorisation	Germany
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Duac Acne Gel®
D.3.4	Pharmaceutical form	Gel
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	benzoyl peroxide
D.3.9.3	Other descriptive name	BENZOYL PEROXIDE
D.3.9.4	EV Substance Code	SUB13020MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/g milligram(s)/gram
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	50
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	clindmycin-2-dihydrogen phosphate
D.3.9.3	Other descriptive name	CLINDAMYCIN-2-DIHYDROGEN PHOSPHATE
D.3.9.4	EV Substance Code	SUB69254
D.3.10	Strength
D.3.10.1	Concentration unit	mg/g milligram(s)/gram
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

MILD TO SEVERE PAPULOPUSTULAR ACNE

E.1.1.1

Medical condition in easily understood language

MILD TO SEVERE ACNE

E.1.1.2

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	17.1
E.1.2	Level	LLT
E.1.2	Classification code	10000519
E.1.2	Term	Acne vulgaris
E.1.2	System Organ Class	100000004858

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

The objective of this trial is to evaluate the efficacy and the tolerability of topically applied 0.1% tyrothricin (Tyrosur® Gel) in patients with mild to severe facial papulopustular acne in comparison to a combination of clindamycin and benzoyl peroxide or to benzoyl peroxide alone

E.2.2

Secondary objectives of the trial

Not applicable

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• Female or male patients 18 - 25 years of age;
• Fitzpatrick skin phototype of I-III [31];
• Written informed consent of the patients and of the parents/legal guardians of minor patients (as applicable);
• Clinical diagnosis of facial mild to severe papulopustular acne with comparable in appearance on both sides of the face;
• The number of inflammatory lesions or non-inflammatory lesions on one half-face must not be greater than twice the number on the other half-face;
• Investigative Static Global Assessment Score (ISGA) of 2 (mild) to 4 (severe);
• Total facial acne inflammatory lesion count (papules and pustules) of no less than 10 but no more than 50;
• Total facial acne non-inflammatory lesion count (open and closed comedones) of no less than 10 but no more than 100;
• Female subjects of childbearing potential must have a reliable negative pregnancy test at baseline and must not be breast feeding. Women of childbearing potential participating in the trial must use highly effective form1 of contraception, if use of a hormonal method, the same drug has to be used since at least 6 month.
• Subjects accepting not to use any antimicrobial topical products (shampoo, soap acne preparation) as well as oral and over the counter (OTC) acne products.
• Non-smokers

E.4

Principal exclusion criteria

• More than 2 nodulo-cystic lesions on each side of the face;
• Other dermatological disorder like: rosacea, atopic dermatitis, perioral dermatitis and psoriasis that may distort the assessment of acne or the assessment of tolerability;
• Planned absences during the course of the trial;
• Known hypersensitivity against or previous allergic reaction to tyrothricin, clindamycin, lincomycin, benzoyl peroxide or any other excipient of the trial medications;
• Previous smoothing or ablative procedures (cryotherapy, fruit acid / TCA peelings, Fraxel Laser etc.) within 3 month prior baseline;
• Intake or use of the following medication :
• Systemic isotretinoin (within the last 6 months prior baseline);
• Systemic antibiotics (within the last 4 weeks prior baseline);
• Systemic corticosteroids (within the last 4 weeks prior baseline);
• Systemic non-steroidal anti-inflammatory drugs in dosage for the treatment of inflammations (within the last 4 weeks prior baseline);
• Topical retinoids (extensive application over the body or in the face within the last 2 weeks prior baseline);
• Topical corticosteroids (extensive application over the body or in the face within the last 2 weeks prior baseline);
• Topical use of non-steroidal anti-inflammatory drugs for the treatment of inflammations (extensive application over the body or in the face within the last 2 weeks prior baseline);
• Medications that are reported to exacerbate acne (eg, high-doses of certain vitamins such as vitamin D, vitamin A, and vitamins B2, B6, and B12; haloperidol; halogens such as iodide and bromide; lithium; hydantoin; and phenobarbital) within the last 3 months prior baseline;
• Using the following types of facial products within 2 weeks prior baseline: astringents, toners, abrasives, facial peels containing glycolic or other acids, masks, washes, soaps or gels containing BPO, sulfacetamide sodium or salicylic acid, non-mild facial cleansers, or moisturizers that contain retinol, salicylic acid, or α- or β-hydroxy acids;
• Any severe acute or chronic diseases;
• Participation in a clinical trial in the last 30 days prior baseline or at the same time;
• Intensive UV-exposition or regular visits of solariums within the last 4 weeks prior baseline or during the course of the trial;
• Persons who are institutionalized because of legal or regulatory order.

E.5 End points

E.5.1

Primary end point(s)

- Change of inflammatory lesion count between Baseline and each visit (7 visits)
- Change of non-inflammatory lesion count between Baseline and each visit (7 visits)
- Change of total lesion count between Baseline and each visit (7 visits)
- Change of ISGA score between Baseline and each visit (7 visits)
- Change of follicular fluorescence between Baseline and each visit (7 visits)
- Change of sebum content between Baseline and each visit (7 visits)

E.5.1.1

Timepoint(s) of evaluation of this end point

End of study and trend of the change in variables during study course
(Visit 1-7).

E.5.2

Secondary end point(s)

Not applicable

E.5.2.1

Timepoint(s) of evaluation of this end point

Not applicable

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

observer-blind

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

intraindividual comparison (split-face)

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

At the final visit (or at premature termination of the patient) the patient will receive recommendations for individual acne therapy by the investigator.

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2013-09-05

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-09-23

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2014-03-13

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials